medical device cleaning validation

Thermal Performance Qualification of Cold Chain Shippers

Thermal Performance Qualification of Cold Chain Shippers Thermal Performance Qualification of Cold Chain Shippers The validation of thermal performance in cold chain shippers is critical for ensuring that temperature-sensitive medical devices are stored and transported within specified temperature ranges. Proper…

Tamper-Evident Feature Validation for OTC and Prescription Products

Tamper-Evident Feature Validation for OTC and Prescription Products Tamper-Evident Feature Validation for OTC and Prescription Products The importance of tamper-evident features in pharmaceutical packaging cannot be understated. These features are critical in ensuring the integrity and safety of over-the-counter (OTC)…

Operational Qualification Tests: AHU Functionality and Alarm Verification

Operational Qualification Tests: AHU Functionality and Alarm Verification Operational Qualification Tests: AHU Functionality and Alarm Verification Step 1: Understanding User Requirements Specifications (URS) and Risk Assessment The foundation of any validation effort lies within the User Requirements Specification (URS) and…

Consolidated Validation Reports: When Are They Appropriate?

Consolidated Validation Reports: When Are They Appropriate? Consolidated Validation Reports: When Are They Appropriate? In the pharmaceutical and biologics sector, validation is a critical process that ensures the safety, efficacy, and quality of products. Medical device cleaning validation is a…

Tracking VMP Execution Using Validation Project Plans

Tracking VMP Execution Using Validation Project Plans Tracking VMP Execution Using Validation Project Plans The execution of Validation Master Plans (VMP) is crucial for ensuring compliance with regulatory frameworks and maintaining the quality of products in the pharmaceutical and medical…

How to Validate Electronic Signatures and Audit Trails

How to Validate Electronic Signatures and Audit Trails How to Validate Electronic Signatures and Audit Trails In today’s highly regulated pharmaceutical and medical device industry, ensuring compliance with electronic records is paramount. This comprehensive guidance details a step-by-step process for…

Writing a Risk Assessment for Legacy Equipment Validation

Writing a Risk Assessment for Legacy Equipment Validation Writing a Risk Assessment for Legacy Equipment Validation In the pharmaceutical industry, ensuring compliance with regulations and standards is vital to maintaining quality and safety throughout the validation lifecycle. Legacy equipment, often…

FDA vs EMA Expectations for Stage 2 Process Qualification

FDA vs EMA Expectations for Stage 2 Process Qualification FDA vs EMA Expectations for Stage 2 Process Qualification In pharmaceuticals and medical device manufacturing, ensuring validation of processes is crucial for meeting regulatory compliance and ensuring product quality. This article…